To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.

A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age. N01009

Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline) [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]

Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for partial onset seizures divided by the total number of subjects. If a subject had < 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy, the subject was counted as a non-responder.

Secondary Outcome Measures:

Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline) [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]

Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for all seizure types divided by the total number of subjects. Subjects who withdrew or dropped out before the first 24 hours Evaluation video-EEG with reasons linked to lack of efficacy were considered as non-responders. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).

Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]

A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement.

Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]

A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).

Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]

A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement.

Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]

A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).

Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old [ Time Frame: 48-hours in Evaluation Period and 48-hours in Selection Period ] [ Designated as safety issue: No ]

A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. For children 1 month to less than 6 months old, partial onset seizure counts were based on electroclinical seizures plus electrographic seizures.

Percentage of drop-outs for any reasons during the study [ Time Frame: During the study (up to 20 days) ] [ Designated as safety issue: No ]

Percentage of drop-outs due to lack of efficacy during the study [ Time Frame: During the study (up to 20 days) ] [ Designated as safety issue: No ]

Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy [ Time Frame: During the study (up to 20 days) ] [ Designated as safety issue: No ]

Time to Exit (TTE) during the Evaluation Period [ Time Frame: During Evaluation Period (Day 1 to Day 6) ] [ Designated as safety issue: No ]

For early termination subjects in the Evaluation period the TTE is the time to discontinuing the study for any reason. TTE was defined as the day of study discontinuation - the day of randomization + 1. For completed subjects, the TTE was censored on Day 6.

Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.

Other Name: Keppra

Eligibility

Ages Eligible for Study:

1 Month to 4 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Pediatric patients from 1 month to less than 4 years of age

Pediatric patients diagnosed with refractory partial onset seizures, on a stable regimen of one to two other anti-epileptic drugs and at least 2 partial onset seizures per week in the two weeks prior to screening

Patients must have two partial onset seizures (with corresponding clinical event) during the 48-hour video EEG at screening

Exclusion Criteria:

A ketogenic diet

Previous exposure to levetiracetam

Seizures too close together to count accurately

Treatable seizure etiology

Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease

Diagnosis of a terminal illness

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00175890